BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADVIA Enzymatic Hemoglobin A1c Calibrator (A1c_E CAL)

    Reg #: 2432235 · FEI: 2432235 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    2432235
    FEI Number
    2432235
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    511 Benedict Ave
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Calibrator, Secondary JIT

    Proprietary Names

    ADVIA Enzymatic Hemoglobin A1c Calibrator (A1c_E CAL) Atellica CH Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL) Atellica CH A1c E CAL DM EXL LOCI TNIH Cal Dimension Vista High-Sensitivity Troponin I Calibrator (TNIH Cal) Atellica CH LDL Cholesterol Calibrator (LDLC CAL) ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL) Dimension Vista ECREA Calibrator ADVIA Centaur B-type Natriuretic Peptide Calibrator (BNP CAL) Atellica IM B-type Natriuretic Peptide Calibrator (BNP CAL) Dimension / Dimension Vista Lipase Calibrator Dimension EXL LOCI BRAHMS Procalcitonin Calibrator (LOCI PCT CAL) Atellica CH HDLC Calibrator (HDLC CAL) Atellica CH Urine Albumin Calibrator (UAlb CAL)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility